[Zero defect] Shandong Lixin Pharmaceutical passed the cGMP on-site inspection of the US FDA

近日，Shandong Lixin Pharmaceutical Co., Ltd. received the on-site inspection report issued by the United States Food and Drug Administration (hereinafter referred to as "FDA")，The inspection report is clear，The quality management system of Shandong Lixin Pharmaceutical Co., Ltd. meets the cGMP standard of FDA，With "zero defects" successfully passed the US FDA field inspection。The relevant situation is as follows:

Company Name:Shandong Lixin Pharmaceutical Co., LTD

Check address:No.9 Jinyang Road, Economic Development Zone, Gaoqing County, Zibo City, Shandong Province

Check category:Preapproval inspection

Inspection time:May 15 to May 19, 2023

Scope of inspection:Pemebenzoic acid

Inspection conclusion:Pass the pre-approval check

The on-site inspection is the first time that Shandong Lixin Pharmaceutical Co., Ltd. has passed the FDA on-site inspection, and it is also the third time that Lixin Pharmaceutical has passed the FDA on-site inspection, once again proving that Lixin Pharmaceutical has always maintained an international high standard of quality system。Lixin Pharmaceutical has always adhered to the principle of "quality first", established a perfect quality assurance system, and implemented standardized, procedural and standardized management in strict accordance with GMP norms。

Lixin Pharmaceutical adheres to global norms and has been certified by FDA, EDQM, EMA and PMDA for many times。In the future, Lixin Pharmaceutical will further accelerate the process of internationalization, enhance the share and influence of products in the international market, and provide high-quality integrated services for global partners。